Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of BPI-9016M with single doses and multiple doses.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, locally advanced, or metastatic solid tumor that progressed, or failed to respond to, at least one prior systemic therapy

• Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)

• Life expectancy ≥3 months

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Adequate bone marrow, hepatic, and renal function

• Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment

• Signed Informed Consent Form

Exclusion Criteria:

• Prior treatment with agents of HGF/c-Met inhibitors or HGF/c-Met antibody(Including Crizotinib,Cabozantinib,Volitinib etc.)

• Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment

• History of organ transplant; had surgery or severe injury within 4 weeks

• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 2, except for alopecia

• Any evidence of severe or uncontrolled systemic diseases, including CTCAE 3 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease

• Pregnant (positive pregnancy test) or lactating women

• Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease

• Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance

• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)

• Inability to comply with study and follow-up procedures

• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications